Enlivex receives CTA approval by DKMA for Phase 2b trial of Allocetra

Enlivex announced that it has received Clinical Trial Application, CTA, approval by the Danish Medicines Agency, DKMA, for the Phase 2b trial of Allocetra, the Company’s clinical-stage immunotherapy, for the treatment of patients with moderate-to-severe age-related symptomatic primary knee osteoarthritis, OA. The planned global, multicenter, randomized, double-blind, placebo-controlled Phase 2b clinical trial, recently approved by the FDA, has been designed to evaluate the efficacy and safety of intra-articular injections of Allocetra in patients with moderate-to-severe age-related symptomatic primary knee osteoarthritis, which is one of the most prevalent and disabling diseases worldwide, affecting more than 32 million Americans today and projected to impact 78 million Americans by 2040. The clinical trial is designed to enroll patients from clinical centers in the United States, Denmark and Poland.